Clinical Protocol and Data Management

University Of California At Davis, Davis CA

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY/ABSTRACT Part I: Clinical Protocol and Data Management. The UCDCCC Office of Clinical Research (OCR), formerly the Clinical Trials Support Unit, is led by Associate Director for Clinical Research (Karen Kelly, MD) and OCR Executive Director (Cinda Lyon, RN). The OCR includes five units: operations, business, regulatory, phase I and clinical, thus providing cancer center investigators with a centralized resource providing a full repertoire of services to conduct clinical trials. The OCR staff work cohesively with the Investigators to provide subjects with exceptional care such that toxicities are minimized, trial adherence is maintained and data quality is achieved. Part II: Data and Safety Monitoring. All clinical trials conducted under the auspices of UCDCCC include provisions for data and safety monitoring. The Data Safety and Monitoring Plan (DSMP) focuses on patient safety, protocol adherence and quality of data. It was recently revised to provide oversight of clinical trial conduct in accordance with NCI guidelines. Part III: Inclusion of Minorities and Women in Clinical Trials. The UCDCCC is dedicated to the inclusion of women and minorities in our cancer clinical trials and complies with the NIH regulations on accrual of these populations. Entry criteria for cancer studies are disease, not gender or ethnicity specific. The sex/gender and racial/ethnic makeup of the study population for any one trial will be influenced by the frequency of the diagnosis in various subgroups. We offer clinical trials focused on cancers for which minority populations experience disparities, for example, liver cancer (Asian Americans and all populations of color), prostate cancer (African Americans and Hispanics), and breast cancer (African Americans, Hispanics, and Asian Americans). Although protocols are open to women who meet the eligibility criteria, pregnant and nursing women are excluded because of unknown risks of anti-neoplastic agents to fetuses and infants. Part IV: Inclusion of Children in Clinical Trials. UCDCCC, through the Pediatric Oncology Division, offers a large variety of clinical cancer research trials to the children of Sacramento and the surrounding area. These trials address a wide variety of pediatric malignancies, including (but not limited to) leukemia/lymphoma, osteosarcoma, Wilms Tumor and neuroblastoma.